Study on Using Nicotine Electronic Cigarettes and Varenicline for Smoking Cessation in Smokers of 10+ Cigarettes Daily

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What is this study about?

This clinical trial is focused on helping people who smoke at least 10 cigarettes a day to quit smoking. The study is comparing three different methods to assist with smoking cessation: electronic cigarettes with nicotine, electronic cigarettes without nicotine, and a medication called . Varenicline is a treatment that comes in the form of film-coated tablets and is known by the brand name . It is a licensed medication used to help people stop smoking.

The purpose of the study is to evaluate how effective electronic cigarettes containing nicotine are compared to electronic cigarettes without nicotine and to . Participants in the study will be randomly assigned to one of these three groups. The study will last for a period of three months, during which participants will be monitored to see if they can stop smoking continuously for the last four weeks of the treatment period. The study will also look at the safety of these methods by comparing any serious or non-serious side effects that may occur.

Throughout the study, researchers will also assess other factors such as the time it takes for participants to relapse into smoking after their target quit day, changes in the number of cigarettes smoked per day, cravings for tobacco, and withdrawal symptoms. The goal is to find out which method is most effective and safe for helping people quit smoking.

1 joining the study

Upon joining the study, participants are randomly assigned to one of three groups: electronic cigarettes with nicotine, electronic cigarettes without nicotine, or varenicline.

The study is designed to be double-blind, meaning neither the participants nor the researchers know which group each participant is in.

2 medication administration

Participants in the varenicline group receive CHAMPIX 0.5 mg film-coated tablets for oral use. The dosage and frequency are determined by the study protocol.

Participants in the electronic cigarette groups use either nicotine-containing or nicotine-free electronic cigarettes as per their group assignment.

3 treatment period

The treatment period lasts for 3 months. During this time, participants are expected to follow the assigned treatment regimen.

Participants are monitored for smoking abstinence, which is defined as not smoking during the last 4 weeks of the treatment period.

4 monitoring and assessments

Throughout the study, participants attend regular visits for monitoring and assessments.

Assessments include self-reported smoking abstinence, measurement of expired air carbon monoxide levels, and evaluation of any adverse events.

Additional assessments focus on changes in cigarette consumption, cravings, and withdrawal symptoms.

5 end of treatment evaluation

At the end of the 3-month treatment period, participants undergo a final evaluation to assess their smoking status and any changes in health or behavior.

The primary goal is to determine the continuous smoking abstinence rate and compare the effectiveness of the different treatments.

Who Can Join the Study?

Must be a smoker who has been smoking at least 10 cigarettes per day, whether factory-made or roll-your-own, in the past year.
Must be between the ages of 18 and 70 years old.
Must be motivated to quit smoking, which means scoring more than 5 on a visual rating scale from 0 (not motivated at all) to 10 (extremely motivated).

Who Cannot Join the Study?

People who have smoked at least 10 cigarettes a day in the past year cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Hopital Antoine Beclere	Clamart	France
Centre Hospitalier Saint Joseph Saint Luc	Lyon	France
Hopital Beaujon	Clichy	France
Dispensaire Emile Roux	Clermont Ferrand	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Clmxgc Hjqzfvwracw Hqcyw Lwnupik	Poitiers	France
Cvc Ckjbchyv Sbslsri dr Ntlyoekaee	Nimes	France
Cphd Db Nvpjz	Vandoeuvre Les Nancy	France
Cgyruv Huuuipkcyge Rmzqvtmd Dnvzficqiamlti	Angers	France
Ianayvkz dm Cnifcsxgrhay Hbeuqyivppk Ukedlvjakcipj dx Sgoym Enemfxh (zthyvzx	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	17.10.2018

Trial locations

Investigated drugs:

Varenicline

Electronic Cigarettes with Nicotine (ECwN) are used in this trial to help people stop smoking. These e-cigarettes contain nicotine, which is the addictive substance found in traditional cigarettes. The goal is to see if using these e-cigarettes can help people quit smoking by providing a similar experience to smoking a regular cigarette but with less harmful effects.

Electronic Cigarettes without Nicotine (ECwoN) are also part of the trial. These e-cigarettes do not contain nicotine, so they do not have the addictive component of regular cigarettes. The purpose of including these is to determine if the act of using an e-cigarette, without the nicotine, can still help people quit smoking by mimicking the physical habit of smoking.

Varenicline is a medication used to help people stop smoking. It works by reducing cravings and withdrawal symptoms associated with quitting smoking. Varenicline also blocks the effects of nicotine from cigarettes, which can help reduce the pleasure derived from smoking. This medication is included in the trial as a reference to compare its effectiveness against the electronic cigarettes.

Nicotine Dependence – Nicotine dependence is a condition characterized by an addiction to nicotine, a chemical found in tobacco products. It develops as individuals repeatedly use tobacco, leading to physical and psychological reliance. Over time, the body becomes accustomed to nicotine, requiring more to achieve the same effects. This dependence can result in withdrawal symptoms when nicotine use is reduced or stopped. Symptoms may include irritability, anxiety, difficulty concentrating, and increased appetite. The condition often leads to continued tobacco use despite awareness of its harmful effects.

Trial ID:

2024-518135-10-00

Protocol code:

P150952J

NCT ID:

NCT03630614

Trial Phase:

Therapeutic confirmatory (Phase III)

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